VENETOCLAX - Generic Drug Details

What are the generic drug sources for venetoclax and what is the scope of freedom to operate?

Venetoclax is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Venetoclax has two hundred and sixty-four patent family members in forty-three countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for VENETOCLAX

International Patents:	264
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	661
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VENETOCLAX
What excipients (inactive ingredients) are in VENETOCLAX?	VENETOCLAX excipients list
DailyMed Link:	VENETOCLAX at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VENETOCLAX

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VENETOCLAX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Princess Maxima Center for Pediatric Oncology	PHASE1
AstraZeneca	PHASE1
Break Through Cancer Foundation	PHASE1

See all VENETOCLAX clinical trials

Generic filers with tentative approvals for VENETOCLAX

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET
		50MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for VENETOCLAX

Drug Class	BCL-2 Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors
Physiological Effect	Increased Cellular Death

Anatomical Therapeutic Chemical (ATC) Classes for VENETOCLAX

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for VENETOCLAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VENCLEXTA	Tablets	venetoclax	10 mg, 50 mg and 100 mg	208573	2	2020-04-13

US Patents and Regulatory Information for VENETOCLAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes				Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No			Y

EU/EMA Drug Approvals for VENETOCLAX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Venclyxto	venetoclax	EMEA/H/C/004106Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Venclyxto monotherapy is indicated for the treatment of CLL:- in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.	Authorised	no	no	no	2016-12-04

International Patents for VENETOCLAX

Country	Patent Number	Title	Estimated Expiration
Uruguay	33047	AGENTES INDUCTORES DE APOPTOSIS PARA EL TRATAMIENTO DEL CÁNCER Y DE ENFERMEDADES INMUNES Y AUTOINMUNES
Japan	2022091996	タイプＩＩ抗ＣＤ２０抗体と選択的Ｂｃｌ－２インヒビターの併用療法
South Korea	102158467
New Zealand	630166	Combination therapy of a type ii anti-cd20 antibody with a selective bcl-2 inhibitor
Portugal	2576546
South Africa	201401440

Supplementary Protection Certificates for VENETOCLAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435432	2017023	Norway		PRODUCT NAME: VENETOKLAKS, DVS. 4-(4-(2-(4-; REG. NO/DATE: EU/1/16/1138 20161213
2435432	2017/023	Ireland		PRODUCT NAME: VENETOCLAX (VENCLYXTO); REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432	1790021-8	Sweden		PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138 20161207
2435432	386 50008-2017	Slovakia		PRODUCT NAME: VENETOKLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432	LUC00020	Luxembourg		PRODUCT NAME: VENETOCLAX (VENCLYXTO); AUTHORISATION NUMBER AND DATE: EU/1/16/1138 20161207
2435432	C20170017 00231	Estonia		PRODUCT NAME: VENETOKLAKS;REG NO/DATE: EU/1/16/1138 07.12.2016

Market Dynamics and Financial Trajectory for Venetoclax

Last updated: November 14, 2025

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Introduction

Venetoclax, marketed primarily under the brand name Venclyxto (Europe) and Venclexta (United States), represents a significant advancement in targeted cancer therapy. As a BCL-2 inhibitor, Venetoclax has transformed treatment paradigms for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). Analyzing its market dynamics and financial trajectory uncovers critical insights into its commercial adoption, competitive positioning, and future growth prospects amid evolving oncology landscapes.

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Pharmacological Profile and Clinical Impact

Venetoclax functions by selectively inhibiting B-cell lymphoma 2 (BCL-2), an anti-apoptotic protein overexpressed in various hematologic malignancies. Its approval by the U.S. Food and Drug Administration (FDA) in 2016 for CLL with 17p deletion and subsequently for AML and other indications catalyzed its rapid clinical integration. The drug’s efficacy, demonstrated in numerous pivotal trials—such as MURANO for CLL—has solidified its position as a cornerstone therapy, often in combination, enhancing patient outcomes significantly.

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Market Size and Growth Drivers

1. Expanding Hematologic Oncology Market

The global hematologic oncology market, valued at approximately USD 20 billion in 2022, is projected to grow with a compound annual growth rate (CAGR) of over 8% through 2030[1]. Venetoclax’s key indications, prevalent in aging populations with a high incidence of CLL and AML, serve as primary growth engines. Increasing diagnosis rates, especially in developed markets, bolster the demand.

2. Adoption in Combination Therapies

Venetoclax's integration into combination regimens—paired with agents like obinutuzumab, azacitidine, or decitabine—has expanded therapeutic options, bolstered efficacy, and improved resistance profiles. Regulatory approvals for these combinations, such as the FDA's approval of Venetoclax with azacitidine or decitabine for newly diagnosed AML in elderly/unfit patients, have broadened its use and revenue streams[2].

3. Market Penetration in Emerging Economies

Emerging markets present untapped potential owing to increasing healthcare infrastructure and rising prevalence of hematologic malignancies. Local authorities' evolving reimbursement policies and global pharma companies’ strategic expansion efforts are likely to accelerate penetration in these regions.

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Competitive Landscape

Venetoclax faces competition from several agents:

• idamide and other BCL-2 family inhibitors in development.
• Chemoimmunotherapy regimens traditionally used in CLL and AML.
• Emerging targeted therapies, such as FLT3 and IDH inhibitors, targeting specific AML mutations.

Despite competition, Venetoclax’s proven efficacy, especially in combination regimens, has reinforced its market dominance. Its relatively favorable safety profile lends an edge over conventional chemotherapy, fueling sustained adoption.

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Regulatory and Patent Landscape

Initial patents granted to AbbVie and Genentech (through Roche) have provided exclusivity periods expiring around 2027-2029. Patent expiries could impact pricing and generic entry opportunities, although the biologic nature of Venetoclax complicates rapid biosimilar development. Regulatory approvals continue to expand indications, reinforcing its commercial viability.

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Financial Trajectory and Revenue Projections

Current Revenue Performance

AbbVie, which acquired Syntex Pharmaceuticals (original developer) in 2019, reported Venclexta/Venclyxto revenue nearing USD 2.2 billion in 2022, accounting for a significant portion of its oncology portfolio[3]. Growth momentum is driven by:

• Rising prescriptions in CLL, particularly in North America and Europe.
• Growing usage in AML, especially after approval for newly diagnosed elderly patients.
• Strong pipeline-driven expansion into other hematologic malignancies like multiple myeloma and MDS.

Forecasted Growth Trends

Analysts project Venetoclax’s revenues will ascend at a CAGR of approximately 11-14% over the next five years, reaching USD 4.5 billion by 2027. This projection reflects:

• Increased adoption in AML, driven by accumulating clinical evidence.
• Approvals for new indications, including potentially solid tumors.
• Geographic expansion, notably into Asia-Pacific and Latin America markets.

Pricing Dynamics and Access

Pricing strategies remain a key financial determinant. In the U.S., the wholesale acquisition cost (WAC) for Venetoclax exceeds USD 12,000 per month, with payers negotiating substantial discounts. In Europe, reimbursement negotiations and pricing regulations influence net revenues. As patents approach expiry, generic biosimilars could introduce price erosion but also increase accessibility, potentially expanding patient populations.

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Market Challenges and Risks

• Patent Expirations and Biosimilar Competition: Potential dilution of revenue post-2027-2029.
• Pricing Pressures and Reimbursement Policies: Globally, governments are scrutinizing oncology drug prices, which may temper revenue growth.
• Clinical and Regulatory Risks: New competitors, alternate therapies, or unfavorable trial outcomes could impact market share.
• Clinical Adoption Barriers: Physician familiarity, treatment guidelines, and side effect management influence uptake velocity.

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Strategic Outlook and Growth Opportunities

AbbVie's strategic initiatives, including ongoing Phase III trials and expansion of indication labels, aim to consolidate Venetoclax's market position. Potential areas include:

• Expansion into solid tumors, given preclinical hints.
• Personalized medicine approaches, identifying patients most likely to benefit.
• Collaborations with biotech firms to develop next-generation BCL-2 inhibitors.

Continual pipeline development and geographic expansion are essential to sustain revenue growth amid competitive and patent landscapes.

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Key Takeaways

• Robust Market Position: Venetoclax’s proven clinical efficacy and combination therapy advantages secure its role as a leading hematologic cancer treatment.
• Revenue Growth Confirmed: Projected revenues will likely increase at a double-digit CAGR, making it a highly valuable asset within AbbVie's portfolio.
• Patent and Competition Risks: Post-2027 patent expiries could temper opportunities but are mitigated by current market share dominance and ongoing innovation.
• Global Expansion Incentives: Entry into emerging markets and Asian jurisdictions will critically influence future sales figures.
• Pipeline and Indication Expansion: Continued clinical development promises additional revenue streams and market penetration, securing Venetoclax's long-term financial trajectory.

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FAQs

1. What are the primary indications for Venetoclax?
Venetoclax is approved for chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML), particularly in elderly or unfit patients, with ongoing trials exploring broader applications.

2. How does Venetoclax differ from other cancer therapies?
As a selective BCL-2 inhibitor, Venetoclax induces apoptosis directly within malignant cells. Its targeted mechanism allows for combination with other therapies, reducing reliance on traditional chemotherapy and minimizing toxicity.

3. When might generic versions of Venetoclax enter the market?
Patent protections are expected to expire around 2027-2029, after which biosimilars could emerge, potentially impacting pricing and sales volumes.

4. What are the main barriers to Venetoclax’s market expansion?
Pricing negotiations, patent expiries, competition from emerging agents, and regulatory hurdles in certain regions can impede rapid expansion.

5. What future clinical developments could influence Venetoclax's market?
Pending approvals for new indications, combination regimens, and exploration in solid tumors could significantly extend its market life and revenue opportunities.

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References

[1] MarketsandMarkets, "Hematologic Oncology Market," 2022.
[2] FDA, "Venclexta (Venetoclax) Prescribing Information," 2016.
[3] AbbVie Annual Report, 2022.